All documents shown here are included in the seminar for instant download

1) Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?

2) George Smith: Update on Part 11

3) George Smith: Risk based computer system validation

The reference material includes links to FDA and international
regulations and guidelines

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
To share this seminar info with your colleagues,
click here.

On-line Audio Seminar 368

Learning from Recent
Warning Letters related to Part 11
and Computer Validation

With Clear Recommendations for Corrective
and Preventive Actions

Recorded, available with all reference material
at any time

Some time ago FDA started the Part 11 inspection initiative.
While originally the initiative was supposed to last
3-6 months,
now it looks more like an ongoing program with Part 11
related issues being part of most inspections. At the
beginning of the initiative FDA made it very clear that Part
11 is in effect and is enforced according to
the original Part 11 and the Guidance from 2003. In
the meantime FDA officials reported about key findings and inspectors regularly
cited deviations related computer validation and other Part 11 issues. For
example, George Smith who heads up FDA's Part 11 working group gave an update
with examples of violations. Because of missing clear guidance
the industry has lots of questions

What is FDA's most current thinking
related to computers and electronic records?

What are the inspection trends?

What are most frequent recent citations
related to electronic records?

What are the most frequent deviations for
computer system validation?

Under which circumstances can inspectors
exercise enforcement discretion?

How important is risk based Part11
compliance?

When and how to best respond to 483's to
avoid warning letters?

Why do most responses to 483's and Warning Letters fail?

What is the best strategy for future
proven Part 11 compliance?

Are there proven tools that help to
implement strategies?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber
in a new interactive audio seminar. During the seminar, the speaker
will present examples and recommendations on how to avoid
Part 11 related FDA warning letters and 483's.
After the seminar, an extensive list of reference material like case
studies on how to avoid or respond to 483's,
SOPs, checklists and templates will help immediate and cost
effective implementation of a Part 11 program that is in line with
current and future FDA's expectations. The seminar lasts one hour
and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn
about:

FDA inspections: Preparation, conducts,
follow up

The meaning of warning letters and 483
inspectional observations

Learning from an FDA presentation: “Data
Integrity and Fraud - Another Looming Crisis?”

Data integrity and authenticity: FDA's
new focus during inspections

Examples of recent Part 11 related 483’s
and Warning Letters

Examples of recent 483’ and warning
letters related to computer system validation ‘

About audio seminars

Online audio seminars are
presented over the phone. During the live presentation attendees
can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a
seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about
computer system validation and e-records.

Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback: The seminar did meet my
expectations. I always expect a wonderful seminar from Dr. Huber, and
my expectations were once again met. A great time saver for me as I do
not have time to look up recent 483s relating to Part 11 -- worth the
time and cost.
Ms. Diana Mayes, Manager of ABC Laboratories, USA
(Ref T-1077).

Seminar:
FDA's New Enforcement of 21 CFR Part 11
Feedback:
The seminar exceed my
expectations. Webinar was very informative to our current practice and
will help us focus and stream line our process. I would recommend this
seminar to everyone having the same responsibilities.
Ms. Mike Robertson, QA Engineer at Energizer, USA (Ref T-1078).

Seminar:Learning
from Recent FDA Warning Letters Related to Computer Validation and Part
11Feedback:
I basically wanted a overview of
what the FDA is looking for and this webinar fit my needs exactly. I
thought the presentation of the material was done very well, DR Huber is
obviously knowledgeable and he presented the subject matter very
clearly.
Mr. Gene Rideout, Instrumentation
laboratory, Software Quality assurance, R&D, USA (Ref
T-1083).